- What is the NIH Helping to End Addiction Long-termSM Initiative, or the NIH HEAL InitiativeSM?
- What are the NCATS ASPIRE Challenges for Translational Innovation in Pain, Opioid Use Disorder and Overdose?
- Where can I find information about the winning submissions to the NCATS ASPIRE Design Challenges?
- May a person, team, or entity apply to the Reduction-to-Practice Challenge without having submitted a design to the NCATS ASPIRE Design Challenges?
- May a Design Challenge winner apply to the NCATS ASPIRE Reduction-to-Practice Challenge?
- What is a prize competition?
- What are some advantages to using the prize competition mechanism?
- May non-U.S. citizens and/or non-permanent residents participate in the challenge?
- May federal employees participate in the challenge?
- Is an account with Challenge.gov required to compete?
- What will be the method of payment?
- How will prizes be awarded?
- May innovators fund development of submissions with federal funds?
- What are the options for participating in this challenge without using federal funds?
- Who will evaluate submissions and select winners?
- Who are the subject matter experts (SMEs)?
- Who are the federal judges?
- May innovators participate on multiple teams?
- What information should be included in a submission?
- May an innovator’s qualifications statement exceed five pages? What should be included in the qualifications statement?
- When should teams form, and what is NCATS’ level of involvement with the teams?
- Are preliminary data required for the planning stage of the Reduction-to-Practice Challenge?
- Are innovators required to use a particular data set?
- Will submissions to advance in vivo biological assays be considered?
- May innovators ask additional questions?
What is the NIH Helping to End Addiction Long-termSM Initiative, or the NIH HEAL InitiativeSM?
The HEAL Initiative is a trans-agency effort to address the national opioid epidemic. The initiative will bolster research to improve treatments for opioid misuse and addiction and enhance pain management. More information can be found here: www.nih.gov/research-training/medical-research-initiatives/heal-initiative.
What are the NCATS ASPIRE Challenges for Translational Innovation in Pain, Opioid Use Disorder and Overdose?
Through the NCATS ASPIRE Challenges, NCATS aims to develop innovative and catalytic approaches to help solve the opioid crisis through development of next generation non-addictive analgesics with new chemistries, data-mining and analysis tools and technologies, as well as biological assays that will revolutionize discovery, development and pre-clinical testing of new and safer treatments of pain, opioid use disorder and overdose.
In the NCATS ASPIRE Design Challenges, the first phase, NCATS asked for innovative ideas to be submitted as concept proposals. Prizes were awarded for each of the design challenges. To view the list of winners, please see: ncats.nih.gov/aspire/2018ChallengeWinners.
In the distinct, follow-on NCATS ASPIRE Reduction-to-Practice Challenge, the second phase, NCATS is asking for the further scientific and technological development of a comprehensive integrated solution to pain, opioid use disorder, and/or overdose. The ASPIRE Reduction-to-Practice Challenge comprises three stages: planning, prototype development and milestones delivery, and prototype delivery and validation/testing.
Reduction-to-practice Challenge: Expected challenge kick-off November 2020
- Open to all eligible innovators. Design Challenge winners are encouraged to revise and resubmit their ideas to the reduction-to-practice stage.
- New teams with innovative ideas are encouraged and will be allowed to enter the challenge at this phase
Where can I find information about the winning submissions to the NCATS ASPIRE Design Challenges?
Abstracts for the winning designs may be found here: ncats.nih.gov/aspire/2018ChallengeWinners.
May a person, team, or entity apply to the Reduction-to-Practice Challenge without having submitted a design to the NCATS ASPIRE Design Challenges?
Yes. Innovators in the Reduction-to-Practice Challenge do not need to have submitted a design to the ASPIRE Design Challenges. This Challenge is an open competition and new submissions with novel solutions are encouraged.
May a Design Challenge winner apply to the NCATS ASPIRE Reduction-to-Practice Challenge?
Yes. Winners of the NCATS ASPIRE Design Challenges are encouraged to apply to the Reduction-to-Practice Challenge. Winners of Challenge 5 (the Integrated Solution Challenge) of the Design Challenges must develop plans such that all four component areas (integrated chemistry database, electronic synthetic chemistry portal, predictive algorithms, and biological assays) are integrated into their comprehensive platforms.
What is a prize competition?
For a prize competition, or “challenge,” a monetary award is offered to a winning innovator(s) whose solution meets the judging criteria. Success depends on meeting the challenge’s defined scientific goals. The America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Reauthorization Act of 2010 (America COMPETES Act) is the original prize authority. The American Innovation and Competitiveness Act (AICA) updated this federal prize competition authority in December 2016 under the Science Prize Competition Act section. In addition to stimulating innovation that has the potential to advance the agency’s mission, these pieces of legislation encourage public-private partnerships and commercialization of final products.
What are some advantages to using the prize competition mechanism?
A prize competition provides the best means of achieving the objectives of the NCATS ASPIRE Program because it addresses the intractable problem of transforming synthetic chemistry from an empirical endeavor to a predictive undertaking, While certain capabilities exist under other funding instruments available to NCATS, the constellation of capabilities required to reward and spur the degree of innovation, collaboration and transparency requisite to advance the NCATS ASPIRE Program, at a pace appropriate to address a public health emergency, is best addressed under prize authority. Critical to the success of the program are several capabilities: engage diverse and non-traditional stakeholders, including individuals unaffiliated with an organization, who may not otherwise take advantage of NIH opportunities (e.g., NSF, DARPA and NIST grantees), as well as citizen scientists; ensure high visibility to ignite and sustain interest and momentum through broad advertisement using the federal challenge.gov (www.challenge.gov/) platform to augment traditional means (e.g., the NIH Guide to Grants and Contracts); jumpstart the effort by rapidly identifying successful designs to move toward the immediate scientific objective in the context of the opioid crisis and simultaneously obtain generalizable information to disseminate due to NCATS’ ability to immediately share winning designs with the public; and mitigate risks by awarding cash prizes for completed designs instead of providing funding for yet-to-be-developed designs.
May non-U.S. citizens and/or non-permanent residents participate in the challenge?
Yes. While non-U.S. citizens and non-permanent U.S. residents are not eligible to win a prize (in whole or in part) under the America COMPETES Act, NIH generally permits non-U.S. citizens and non-permanent U.S. residents to register for and participate in NIH challenges. Such individuals may, for example, participate as part of a team that satisfies the applicable eligibility criteria and may be recognized when the results are announced, but they are not permitted to receive any monetary prizes. In addition, entities may also participate in this Challenge provided they are incorporated in and maintain a primary place of business in the United States.
Each team must designate a lead who must be a U.S. citizen or permanent resident and who is responsible for all correspondence regarding this challenge.
The official language regarding eligibility can be found on the NCATS Challenge Details page.
May federal employees participate in the challenge?
Innovators may NOT be a federal entities or federal employees acting within the scope of their employment. Innovators may NOT be employees of HHS acting in a personal capacity. If employed by a federal agency other than HHS, innovators should consult with an ethics official at their respective agencies to determine if participation violates federal ethics rules.
Is an account with Challenge.gov required to compete?
No. A Challenge.gov account is not necessary to participate in the challenge. The challenge announcement will be posted at Challenge.gov, but submissions will NOT be accepted at Challenge.gov.
What will be the method of payment?
Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.
How will prizes be awarded?
Prizes will be awarded directly to each eligible member of the winning team, so award apportionment within a team will need to be specified by the winning teams. All members of winning team(s) will be announced and recognized by NCATS. Winning team members will be listed on the NCATS website and promoted through various other NCATS communications.
May innovators fund development of submissions with federal funds?
No. Innovators may not fund the work to participate in this challenge using federal grant or contract funds. The challenge announcement states that “Federal grantees may not use Federal funds from a grant award to develop their Challenge submissions or to fund efforts in support of their Challenge submissions.” Additionally, the announcement states that “Federal contractors may not use Federal funds from a contract to develop their Submissions or to fund efforts in support of their Submission.” Therefore, alternative funding must be used to do the work.
What are the options for participating in this challenge without using federal funds?
Some ideas for alternate funding sources include using development money from the innovator’s institution, starting a crowdfunding campaign, and applying for grants from non-federal organizations with similar goals and missions.
Who will evaluate submissions and select winners?
All submissions will be evaluated by a team of subject matter experts (SME) who hold expertise and experience directly relevant to the Challenge. The solutions and evaluation statements from the SME team will then be reviewed by federal employees with appropriate expertise and experience who will serve as judges to select the Challenge winners, subject to the final decision by the Award Approving Official.
Who are the subject matter experts (SMEs)?
The subject matter experts (SMEs) on the review teams and site visit teams as well as the staff members in the NCATS-designated laboratories who will evaluate the prototypes, are scientists with cross-disciplinary expertise that will be necessary to best evaluate the submissions. SMEs will have direct experience in the fields of synthetic chemistry, drug discovery and development, database and/or algorithm development, and/or development of novel physiologically relevant biological assays. Pain, addiction and overdose experts will be included as well. The names of the SMEs will be posted on the NCATS ASPIRE webpage upon confirmation of their participation. NCATS reserves the right to add technical consultants upon receipt of submissions, if additional expertise is needed.
Who are the federal judges?
The federal judges will be federal employees who have extensive expertise related to the topics of the challenges, including, but not limited to, a wide spectrum of expertise along the drug discovery and development continuum, 2-D and 3-D biological assay development, stem cell biology, pain biology, bioengineering, and development of tools and technologies for data analysis.
The names of the federal judges will be posted on the NCATS ASPIRE Challenges webpage upon confirmation of their participation. NCATS reserves the right to add members to the judging panels upon receipt of submissions, if additional expertise is needed.
May innovators participate on multiple teams?
Yes. An individual may be a team lead on multiple and clearly distinct submissions and/or a team member on multiple submissions.
What information should be included in a submission?
Please refer to the announcement and submission template for a full description of information that must be included in submissions. One element that must be included is contact information. If participating singly as an individual or entity, please provide your name and affiliation. If participating as a team, please provide the team lead’s name and affiliation, names and affiliation of other team members, and indicate the name of the challenge in which you are competing.
May an innovator’s qualifications statement exceed five pages? What should be included in the qualifications statement?
No. The qualifications statement is limited to five (5) pages. For each team member, NCATS suggests including a brief summary of expertise, any accomplishments that were directly relevant to the team members’ abilities to carry out their roles, and any other information directly relevant to a challenge the innovator is entering.
When should teams form, and what is NCATS’ level of involvement with the teams?
NCATS expects the team formation aspect for challenges to be flexible and of maximum benefit towards addressing the challenge area (i.e., assemble your teams as needed to push the science forward). If you are proposing to incorporate ideas/technology outside your area of expertise, you and the team members with the expertise should agree to work together in advance of submitting the proposal, so that the team members and their expertise can be presented in the ”Research Design and Methods” section of the submission (see the submission template). Teams may also form, add members, divide, or merge at any point during the competition.
Any agreements among innovators who decide to collaborate are at the discretion of those involved. NCATS is not overseeing collaborations, and each team is responsible for its own assembly and disassembly. NCATS simply wants to maximize the flexibility for all innovators, in order to have the best chance of achieving the solution. For example, if a non-winning team finds that it is not feasible to move forward, and the team disassembles, we encourage those with expertise and interest to pursue membership with other teams.
Are preliminary data required for the planning stage of the Reduction-to-Practice Challenge?
No. Preliminary data are NOT required but are allowed.
Are innovators required to use a particular data set?
No. Data may be aggregated from available public and/or private sources, provided that innovators assure that any data used for the purpose of submitting a submission for the Challenge, were obtained legally through authorized access to such data. Please provide the license and terms under which they are provided for all included datasets.
Will submissions to advance in vivo biological assays be considered?
No. The assay must be amenable to high throughput screening in the future.
May innovators ask additional questions?
Questions can be emailed to NCATSASPIREChallenge@mail.nih.gov.